SOCRA CCRP QUESTIONS & ANSWERS WITH
COMPLETE SOLUTIONS GRADED A+
QUESTIONS AND ANSWERS
FDA Part 11. ANSWER -electronic signatures are of the same validity as
handwritten signatures, must provide 2 identifiers and verify identification of signer
FDA Part 50. ANSWER -Food and Drugs, and ICF
FDA Part 56. ANSWER -IRBs
FDA Part 312. ANSWER -investigational new drug application
FDA Part 812. ANSWER -investigational drug exemption
FDA Form 482. ANSWER -Notice of inspection
FDA Form 483. ANSWER -Letter of investigational observations/citation of
noncompliance that specifies how long you have to respond.
FDA Form 3454. ANSWER -Certification - Financial Interests and Arrangements of
Clinical Investigators
FDA Form 3455. ANSWER -Disclosure - Financial Interests and Arrangements of
Clinical Investigators
,FDA Form 3500. ANSWER -For Voluntary Reporting of Adverse Events and
Product Problems
FDA Form 3500A. ANSWER -For Use by User-Facilities, Distributors, and
Manufacturers for Mandatory Reporting
investigator vs. sponsor vs. sponsor-investigator. ANSWER -I: conducts trial
S: initiates trial (manages and finances)
S-I: conducts and initiates trial
minimal risk. ANSWER -probability and magnitude of harm and discomfort are not
greater than those encountered in day-to-day life
Why should an individual be given ample time and sufficient opportunity to consider
whether or not to participate? (2 reasons). ANSWER -1) minimize coercion
2) understandable language
What are exceptions to ICF general requirements? (for emergency use with IRB
approval). ANSWER -1) life-threatening situation necessitating use of test article
2) patient cannot communicate
3) insufficient time to communicate with legal representative
4) no alternative treatment with equal or greater likelihood of saving subject's life
, ___________ reports emergency use to __________ within ______ days. ANSWER -
investigator to IRB in 5 working days
How soon should documentation be submitted to IRB after emergency use?.
ANSWER -within 5 days
ICF should contain. ANSWER -1) explanation of purpose, duration of subject
participation, etc.
2) any possible risks
3) any possible benefits
4) alternative treatments
5) confidentiality and possibility of FDA inspection
6) contact info
7) participation is voluntary
8) removal of PHI from biospecimens and if they will include genome sequencing
9) details of termination/option to withdraw
short form. ANSWER -states elements of ICF were presented orally to subject/legal
rep, requires witness
Who signs short form?. ANSWER -patient and witness; PI and witness also sign
summary
When a short form is required, is the patient given a copy of the short form, the
summary, or both?. ANSWER -both
COMPLETE SOLUTIONS GRADED A+
QUESTIONS AND ANSWERS
FDA Part 11. ANSWER -electronic signatures are of the same validity as
handwritten signatures, must provide 2 identifiers and verify identification of signer
FDA Part 50. ANSWER -Food and Drugs, and ICF
FDA Part 56. ANSWER -IRBs
FDA Part 312. ANSWER -investigational new drug application
FDA Part 812. ANSWER -investigational drug exemption
FDA Form 482. ANSWER -Notice of inspection
FDA Form 483. ANSWER -Letter of investigational observations/citation of
noncompliance that specifies how long you have to respond.
FDA Form 3454. ANSWER -Certification - Financial Interests and Arrangements of
Clinical Investigators
FDA Form 3455. ANSWER -Disclosure - Financial Interests and Arrangements of
Clinical Investigators
,FDA Form 3500. ANSWER -For Voluntary Reporting of Adverse Events and
Product Problems
FDA Form 3500A. ANSWER -For Use by User-Facilities, Distributors, and
Manufacturers for Mandatory Reporting
investigator vs. sponsor vs. sponsor-investigator. ANSWER -I: conducts trial
S: initiates trial (manages and finances)
S-I: conducts and initiates trial
minimal risk. ANSWER -probability and magnitude of harm and discomfort are not
greater than those encountered in day-to-day life
Why should an individual be given ample time and sufficient opportunity to consider
whether or not to participate? (2 reasons). ANSWER -1) minimize coercion
2) understandable language
What are exceptions to ICF general requirements? (for emergency use with IRB
approval). ANSWER -1) life-threatening situation necessitating use of test article
2) patient cannot communicate
3) insufficient time to communicate with legal representative
4) no alternative treatment with equal or greater likelihood of saving subject's life
, ___________ reports emergency use to __________ within ______ days. ANSWER -
investigator to IRB in 5 working days
How soon should documentation be submitted to IRB after emergency use?.
ANSWER -within 5 days
ICF should contain. ANSWER -1) explanation of purpose, duration of subject
participation, etc.
2) any possible risks
3) any possible benefits
4) alternative treatments
5) confidentiality and possibility of FDA inspection
6) contact info
7) participation is voluntary
8) removal of PHI from biospecimens and if they will include genome sequencing
9) details of termination/option to withdraw
short form. ANSWER -states elements of ICF were presented orally to subject/legal
rep, requires witness
Who signs short form?. ANSWER -patient and witness; PI and witness also sign
summary
When a short form is required, is the patient given a copy of the short form, the
summary, or both?. ANSWER -both
